Blood Clearance Kinetics of the Nucleosome and CTCF in Peritoneal Metastasis Colorectal Cancer.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

Colorectal cancer is highly prevalent in France, ranking second among women and third among men. Its primary metastatic sites include the liver, lungs, and peritoneum. For peritoneal metastases, when the disease is moderately extensive, cytoreductive surgery is recommended in an expert centre. Following this procedure, the surgeon uses the CC-Score (Completeness of Cytoreduction after Surgery Score) to assess the completeness of surgical resection by evaluating the largest remaining tumor residue. This subjective score is currently the main prognostic factor for oncological outcomes post-surgery. However, there is no objective score based on biological criteria to evaluate the radicality of resection, despite the hypothesis that the micrometastatic component of the disease could be biologically assessed using appropriate circulating markers.

New biomarkers are emerging and appear relevant for determining the presence of tumor residual disease. Notable among these are circulating tumor DNA, which can detect mutated DNA released by tumor cells into the patient's blood through high-throughput sequencing, and new markers related to epigenetic modifications in cancer cells. These markers target specific nucleosomes or the transcription factor CTCF and show promise in detecting residual disease.

To effectively use these markers for constructing a biological score to detect residual disease in peritoneal carcinomatosis, it is essential to understand their perioperative kinetics. This is crucial because cellular debris release is expected post-surgery, necessitating the determination of the most relevant time point for measurement. Additionally, these markers appear to be correlated with blood inflammation levels, requiring a description of this correlation to account for this potential confounding factor. Finally, the sensitivity and specificity of these markers must be determined by studying their perioperative kinetics in patient groups undergoing surgeries other than cytoreductions for peritoneal carcinomatosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male/female over 18 years of age.

Weight ≥ 55 kg at inclusion.

Signature of a free and informed consent form.

Peritoneal metastases colorectal cancer histologically proven

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood sampling

    Biological/Vaccine

    Inclusion (baseline): 28 mL Incision (surgery): 18 mL End surgery: 18 mL H+12 after end surgery: 18 mL H+4 after end surgery: 18 mL H+48 after end surgery: 18 mL H+72 after end surgery: 18 mL D+7 after end surgery: 18 mL D+14 after surgery: 18 mL 4 to 6 weeks after surgery:28 mL

Treatment groups

58 Participants
are divided into 5 treatment groups
Group A: Peritoneal metastases colorectal cancerExperimental treatment 1 intervention
Group B: Colorectal cancerExperimental treatment 1 intervention
Group C: Non-oncological chronic inflammatory diseasesExperimental treatment 1 intervention
Group D: Non-malignant diseasesExperimental treatment 1 intervention
Group E: Abdominal sepsis conditionsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Kinetic of nucleosome and CCCTC-binding factor (CTCF)

Blood clearance kinetics of the nucleosome (H3K27me3, H3K36me3, H3.1 et H3K9me3) and CCCTC-binding factor (CTCF).

Time frame
From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.

Secondary outcomes

1

Kinetic of inflammatory markers - Albumin

Blood clearance kinetics of albumin

Time frame
From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
2

Kinetic of inflammatory markers - C-reactive protein

Blood clearance kinetics of C-reactive protein

Time frame
From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
3

Kinetic of inflammatory markers - Interleukin IL-6

Blood clearance kinetics of Interleukin IL-6

Time frame
From the inclusion (baseline) to 4 to 6 weeks after surgical procedure.
4

Correlation between inflammatory markers, nucleosome and CCCTC-binding factor (CTCF).

Correlation test between blood concentration of inflammatory markers (albumin, C-reactive protein, Interleukin IL-6), nucleosome nucleosome (H3K27me3, H3K36me3, H3.1 et H3K9me3) and CCCTC-binding factor (CTCF).

Time frame
Completed postoperative follow-up : at least 4 to 6 weeks after surgery

Other outcomes

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